MSACL 2026 Abstract

A Structured Productivity Challenge Study of a Fully Automated Mass Spectrometry System

Katharina Habler, Arber Rexhaj, Michael Vogeser
Institute of Laboratory Medicine, LMU University Hospital, LMU Munich, Germany

Katharina Habler (Presenter) LMU University Hospital, LMU Munich

Relevant Financial Disclosures (within past 24 months, reported on Apr 09, 2026) No relevant financial relationship(s) to disclose.

INTRODUCTION:
The fully automated Cobas® i601 analyzer (Roche Diagnostics) is intended for continuous 24-hour random-access operation in routine clinical laboratories for mass spectrometry-based analyses. The present study aimed to systematically evaluate the system’s throughput, robustness, usability, walk-away time, and precision, together with the performance of the first commercially available reagents, under extended high-throughput conditions in a clinical laboratory.

METHODS:
As no established standardized procedure is currently available for such a productivity challenge study, we developed a completely new protocol: Thirteen measurands (Cortisol, Cortisone, 17-OH-Progesterone, Di-hydro-Testosterone, DHEA-S, DHEA, Progesterone, Vitamin D25 and 24, 25 included: 25-OH-Vitamin D3 + 25-OH-Vitamin D2 and 24,25-Di-OH-Vitamin D3 + 24,25-Di-OH-Vitamin D2), implemented in three different reagent configurations, were quantified in aliquots of three human serum pools. The same series layout was applied on four study days. Once reagents, consumables, and samples had been loaded and the respective series had been started, no further operator intervention was necessary until the run was completed.

RESULTS:
In total, 3016 valid quantitative results were generated across the four series. Each series ran for 6 hours without the need for operator intervention, representing the minimum walk-away time. This corresponded to an average throughput of 119 analyses per hour. Measurements of the human serum pools showed total CVs below 4% in most cases.

CONCLUSION:
In this high-throughput evaluation performed in a routine clinical laboratory, the fully automated MS measurements showed performance and productivity characteristics consistent with the manufacturer’s reported specifications, particularly with respect to calibration stability, precision, analytical throughput, and walk-away time.